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Nevin Manimala Statistics

Children and families with chronic pediatric acquired brain injury in need of rehabilitation: characteristics and main challenges in daily life

Disabil Rehabil. 2024 Jul 13:1-10. doi: 10.1080/09638288.2024.2376936. Online ahead of print.

ABSTRACT

PURPOSE: To increase our understanding of child and parent characteristics, family functioning and main challenges in daily life in children and families in need of rehabilitation in the chronic phase of pediatric acquired brain injury (pABI).

METHODS: Fifty-eight children (aged 6-16, 48% girls) were included at least one year post ABI. Demographics and questionnaire data regarding children’s symptom burden, parents’ emotional symptoms and family functioning were collected. Children and parents named their main pABI-related challenges in daily life, and these were categorized in accordance with the International Classification of Functioning, Disability and Health (ICF). Descriptive statistical analyses were performed.

RESULTS: Parents’ emotional symptom loads were high; 22.3% had moderate, moderate-severe or severe depression symptoms while the equivalent number for anxiety symptoms was 17.9%. Problematic family functioning was reported by 32.1% of parents. When asked about their main pABI-related challenges in daily life, 69% of children named school. The most frequent ICF chapters for children and parents were school education, energy and drive functions (mainly fatigue), and emotional functions. Codes spanned across all ICF-domains.

CONCLUSIONS: Rehabilitation for pABI should have a broad, interdisciplinary, and family-centered approach, with school, fatigue, and emotional functioning of parents and children as potential core elements.

PMID:39001694 | DOI:10.1080/09638288.2024.2376936

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Nevin Manimala Statistics

Fetal thymus size in pregnant women with Hashimoto disease

J Clin Ultrasound. 2024 Jul 13. doi: 10.1002/jcu.23764. Online ahead of print.

ABSTRACT

PURPOSE: This study compared fetal thymic-thoracic ratios and fetal thymus transverse diameter measurements in pregnant women with Hashimoto’s thyroiditis (HT) and non-immune hypothyroidism.

METHODS: The study included a total of 141 pregnant women in three groups: 41 with HT, 50 with non-immune hypothyroidism, and 50 healthy individuals. Fetal thymus transverse diameter and thymic-thoracic ratio were compared between these groups.

RESULTS: The mean fetal thymic-thoracic ratio was greater in pregnant women with HT than in the healthy controls (p = 0.031). Mean fetal thymus transverse diameter showed no statistically significant difference between the groups.

CONCLUSIONS: Maternal HT was associated with an increased fetal thymic-thoracic ratio. More comprehensive studies are needed on this subject.

PMID:39001684 | DOI:10.1002/jcu.23764

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Nevin Manimala Statistics

Trends in primary care blood tests prior to lung and colorectal cancer diagnosis-A retrospective cohort study using linked Australian data

Cancer Med. 2024 Jul;13(14):e70006. doi: 10.1002/cam4.70006.

ABSTRACT

INTRODUCTION: Abnormal results in common blood tests may occur several months before lung cancer (LC) and colorectal cancer (CRC) diagnosis. Identifying early blood markers of cancer and distinct blood test signatures could support earlier diagnosis in general practice.

METHODS: Using linked Australian primary care and hospital cancer registry data, we conducted a cohort study of 855 LC and 399 CRC patients diagnosed between 2001 and 2021. Requests and results from general practice blood tests (six acute phase reactants [APR] and six red blood cell indices [RBCI]) were examined in the 2 years before cancer diagnosis. Poisson regression models were used to estimate monthly incidence rates and examine pre-diagnostic trends in blood test use and abnormal results prior to cancer diagnosis, comparing patterns in LC and CRC patients.

RESULTS: General practice blood test requests increase from 7 months before CRC and 6 months before LC diagnosis. Abnormalities in many APR and RBCI tests increase several months before cancer diagnosis, often occur prior to or in the absence of anaemia (in 51% of CRC and 81% of LC patients with abnormalities), and are different in LC and CRC patients.

CONCLUSIONS: This study demonstrates an increase in diagnostic activity in Australian general practice several months before LC and CRC diagnosis, indicating potential opportunities for earlier diagnosis. It identifies blood test abnormalities and distinct signatures that are early markers of LC and CRC. If combined with other pre-diagnostic information, these blood tests have potential to support GPs in prioritising patients for cancer investigation of different sites to expedite diagnosis.

PMID:39001673 | DOI:10.1002/cam4.70006

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Diagnostic accuracy of voluntary and stimulated neuromuscular jitter studies in ocular myasthenia gravis

Muscle Nerve. 2024 Jul 13. doi: 10.1002/mus.28202. Online ahead of print.

ABSTRACT

INTRODUCTION/AIMS: There is a lack of studies comparing the accuracy of neuromuscular jitter analysis during voluntary activation (v-jitter study) versus axonal stimulation (s-jitter study). The study aimed to compare these two techniques in the same population of patients with suspected ocular myasthenia gravis (OMG).

METHODS: Fourteen control subjects (mean age: 55.5 ± 15.2 years) and 34 patients with suspected OMG (mean age: 59 ± 13.9 years) were prospectively evaluated. Twenty spike pairs and 30 individual spikes were analyzed during v-jitter and s-jitter study, respectively. Two different criteria for abnormal individual jitter values were evaluated: ≥ or > than 10% values exceeding the upper normal limit.

RESULTS: OMG was diagnosed in 19 patients based on clinical and laboratory findings, without considering jitter measurements. In most patients, v-jitter and s-jitter analyses provided comparable results. The maximum sensitivity (89%) was achieved with s-jitter study using the ≥10% criterion, while the maximum specificity (93%) was found with v-jitter study using the >10% criterion.

DISCUSSION: Both v-jitter and s-jitter studies showed good to very good accuracy for the diagnosis of OMG, in the absence of any statistically significant difference. Therefore, the patient’s cooperation level and examiner’s experience should guide the choice of performing v-jitter or s-jitter analysis in patients with suspected OMG.

PMID:39001646 | DOI:10.1002/mus.28202

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Nevin Manimala Statistics

Validating motor delays across the developmental coordination disorder-questionnaire and the Vineland adaptive behavior scales (VABS) in children with autism spectrum disorderASD: A SPARK dataset analysis

Autism Res. 2024 Jul 13. doi: 10.1002/aur.3189. Online ahead of print.

ABSTRACT

Motor delays in children with autism spectrum disorder (ASD) are being increasingly recognized using a brief screening tool, called the Developmental Coordination Disorder-Questionnaire (DCD-Q). Further validation of these motor delays using a more robust normed, developmental measure is clearly warranted. In this analysis, a nationally representative sample from the SPARK study was used wherein parents completed the DCD-Q and a more widely used developmental/adaptive functioning measure, called the Vineland Adaptive Behavior Scales (VABS); which comprises of various developmental domains including the motor domain (N = 2,644 completed the DCD-Q and VABS). Eighty two percent children with ASD had a motor delay based on their DCD-Q scores whereas 77% children with ASD had a motor delay based on their VABS motor domain scores. Approximately 70% children with ASD had concurrent motor delay on the DCD-Q and the VABS (i.e., positive predictive value of DCD-Q). Furthermore, there was 81.2% accuracy in reporting a risk/no risk of motor delay across both measures. Overall, these statistics align with the recent reports on proportions of children with ASD having motor delays. Parents of ~70% children with ASD are reporting motor delays that are corroborated across two different motor measures. This not only validates the motor delays reported based on the DCD-Q but also indicates the need for concurrent motor screening using both DCD-Q and VABS for better detection of motor delays in children with ASD. Only 10%-32% of the current SPARK sample received any physical or recreational therapies. This mismatch between presence of motor delays and the lack of access to motor services highlights the need for more motor intervention referrals for children with ASD.

PMID:39001643 | DOI:10.1002/aur.3189

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Radiological cervical foraminal stenosis severity and morphology as a predictor of pre-operative function and functional surgical outcome

Br J Neurosurg. 2024 Jul 12:1-9. doi: 10.1080/02688697.2024.2376647. Online ahead of print.

ABSTRACT

BACKGROUND: Cervical foraminal stenosis on MRI may be assessed using the Kim, modified Kim or Siller methods. This study aimed to investigate which morphological features of cervical foraminal stenosis in patients with cervical radiculopathy correlated best with pre-operative and post-operative surgical outcome following Anterior Cervical Discectomy (ACD) or a Posterior Cervical Foraminotomy (PCF).

METHODS: Pre-operative MRIs of adults with cervical radiculopathy were assessed by six raters. The following measurements were made; uncompressed nerve root diameter, maximal compressed nerve root diameter, anterior & posterior compression, length of the neuroforaminal canal where the diameter was less than the uncompressed nerve root diameter and the distance of maximum compression from the apex of the ligamentum flavum. The Kim, modified Kim and Siller grades were calculated. Neck Disability Index (NDI) was measured pre-operatively and six weeks post-operatively. The radiological measurements and grades were compared to the pre-operative and change in NDI.

RESULTS: Mean NDI was higher in female (58.2) than male patients (45.6) p = 0.05. No other baseline, operative or radiological factors where significantly associated with the pre-operative NDI. The mean [±SD] post-operative NDI was 14.3 [±22.5]. This represents a change of 37.8 (p < 0.001). The pre-operative NDI correlated strongly with the post-operative NDI but no other patient, operation or radiological factors correlated significantly. Neither pre-operative NDI or change in NDI was statistically different in those treated with ACD and those treated with PCF.

CONCLUSION: There was no association between pre-operative NDI and any of the radiological measurements or radiological grades. Furthermore, whilst surgery significantly improved NDI, for those patients with anterior compression, there was no difference in outcome between those treated with an ACD and those treated with a PCF. Current axial MRIs do not adequately assess the cervical nerve root foramina or predict surgical approach, 3D isotropic acquisition and DTI should be explored.

PMID:39001642 | DOI:10.1080/02688697.2024.2376647

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Complications and putative risk factors for cecal or colonic surgery in dogs: 79 cases (2002-2015)

J Small Anim Pract. 2024 Jul 12. doi: 10.1111/jsap.13763. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the complication rate, mortality rate and putative risk factors for cecal or colonic surgery in dogs.

MATERIALS AND METHODS: A multi-institutional retrospective study including dogs that had undergone surgery that involved the cecum or the colon. Medical records from three referral hospitals were reviewed for patient demographics and clinical data. The association between putative risk factors and survival to discharge or complications was assessed using univariable and multivariable analysis.

RESULTS: Seventy-nine dogs met the criteria to be included in this study. Fifty-five dogs had full thickness incision surgeries, while 24 dogs had partial thickness surgeries. The complication and mortality rates for full thickness and partial thickness cecal/colonic surgeries were not statistically different. The dehiscence rate of colonic anastomosis in this study was four of 47 (8.5%). On univariate analysis, performing full thickness procedures out of hours had an association with increased complications and mortality. On multivariable analysis, no factors were associated with survival to discharge or complications. There was no association of board-certified surgeon presence in surgery with complications or mortality.

CLINICAL SIGNIFICANCE: The performance of full thickness cecal/colonic surgery is not associated with a statistically significant increased risk for complications or mortality compared to partial thickness procedures, with a possible increased risk of complications and mortality in full thickness procedures out of hours.

PMID:39001633 | DOI:10.1111/jsap.13763

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The effect of vitamin E and docosahexaenoic acid ethyl ester on Metabolic Dysfunction-Associated steatotic Liver Disease (MASLD)-A randomised, double-blind, placebo-controlled, parallel-group clinical trial (PUVENAFLD)

Aliment Pharmacol Ther. 2024 Jul 12. doi: 10.1111/apt.18149. Online ahead of print.

ABSTRACT

AIMS: We conducted a clinical trial to determine the efficacy of the combination of vitamin E and/or docosahexaenoic acid (DHA) versus placebo in reducing liver fat content after 6 months of intervention in adults with MASLD.

METHODS: Adults with MASLD were randomised to one of four treatment arms (vitamin E 1000 mg/daily + DHA 1.89 g/daily or combination arm, vitamin E 1000 mg alone, DHA 1.89 g alone or placebo) following a 2:1:1:2 randomisation. The primary objective was to determine the efficacy of DHA + vitamin E versus placebo in reducing hepatic fat fraction (%) relative to baseline after 6 months of intervention. Secondary objectives were to determine the effect of vitamin E or DHA alone versus placebo on reducing liver fat at 6 months.

RESULTS: Our cohort consisted of 203 subjects with a mean age of 51 years, 53% female, 91% White, 59% Hispanic ethnicity. The combination of vitamin E + DHA had no effect on the primary endpoint of reducing hepatic steatosis as determined by MRI-PDFF (p = 0.98). Neither vitamin E alone (p = 0.91) nor DHA alone (p = 0.14) significantly reduced hepatic steatosis compared to placebo. However, the trial was not powered adequately for this analysis. Compared with placebo, no statistically significant differences were detected in the 3-month or 6-month levels for ALT (U/L) or AST (U/L) in all three intervention groups.

CONCLUSIONS: The combination of DHA + vitamin E or either agent alone did not demonstrate efficacy on reducing liver fat or aminotransferases in the studied population.

PMID:39001559 | DOI:10.1111/apt.18149

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The score-goldilocks design for phase 3 clinical trials

J Biopharm Stat. 2024 Jul 12:1-10. doi: 10.1080/10543406.2024.2374850. Online ahead of print.

ABSTRACT

In this paper, we propose a new Bayesian adaptive design, score-goldilocks design, which has the same algorithmic idea as goldilocks design. The score-goldilocks design leads to a uniform formula for calculating the probability of trial success for different endpoint trials by using the normal approximation. The simulation results show that the score-goldilocks design is not only very similar to the goldilocks design in terms of operating characteristics such as type 1 error, power, average sample size, probability of stop for futility, and probability of early stop for success, but also greatly saves the calculation time and improves the operation efficiency.

PMID:39001557 | DOI:10.1080/10543406.2024.2374850

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Nevin Manimala Statistics

Comparative Efficacy of Neoadjuvant Nivolumab Plus Chemotherapy versus Conventional Comparator Treatments in Resectable Non-Small-Cell Lung Cancer: A Systematic Literature Review and Network Meta-Analysis

Cancers (Basel). 2024 Jul 8;16(13):2492. doi: 10.3390/cancers16132492.

ABSTRACT

BACKGROUND: This study aimed to estimate the relative efficacy of neoadjuvant nivolumab in combination with chemotherapy (neoNIVO + CT) compared to relevant treatments amongst resectable non-metastatic non-small-cell lung cancer (rNSCLC) patients.

METHODS: Treatment comparisons were based on a network meta-analysis (NMA) using randomized clinical trial data identified via systematic literature review (SLR). The outcomes of interest were event-free survival (EFS) and pathological complete response (pCR). NeoNIVO + CT was compared to neoadjuvant chemotherapy (neoCT), neoadjuvant chemoradiotherapy (neoCRT), adjuvant chemotherapy (adjCT), and surgery alone (S). Due to the potential for effect modification by stage, all-stage and stage-specific networks were considered. Fixed-effect (FE) and random-effects Bayesian NMA models were run (EFS = hazard ratios [HR]; pCR = odds ratios [OR]; 95% credible intervals [CrI]).

RESULTS: Sixty-one RCTs were identified (base case = 9 RCTs [n = 1978 patients]). In the all-stages FE model, neoNIVO + CT had statistically significant EFS improvements relative to neoCT (HR = 0.68 [95% CrI: 0.49, 0.94]), S (0.59 [0.42, 0.82]), adjCT (0.66 [0.45, 0.96]), but not relative to neoCRT (HR = 0.77 [0.52, 1.16]). NeoNIVO + CT (5 RCTs) had statistically significant higher odds of pCR relative to neoCT (OR = 12.53 [5.60, 33.82]) and neoCRT (7.15 [2.31, 24.34]). Stage-specific model findings were consistent.

CONCLUSIONS: This NMA signals improved EFS and/or pCR of neoNIVO + CT relative to comparators among patients with rNSCLC.

PMID:39001554 | DOI:10.3390/cancers16132492